International safety notice
Alert 2635 (Technosurveillance) - Bard do Brasil Industria e Comercio de Produtos para Saude Ltda.
Brazil / Anvisa · BRA · Aug 7, 2018
Key facts
| Title | Alert 2635 (Technosurveillance) - Bard do Brasil Industria e Comercio de Produtos para Saude Ltda. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Bard Max-Core Disposable Core Biopsy Instrument Technical Name: Biopsy Instrument ANVISA registration number: 80689090089 Risk Class: II Affected model: 14G x 10cm / green Affected serial numbers: Batch Code/Number MC1410 REBP1199 MC1410 REBQ0343 MC1410 REBR0468 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BARD DO BRASIL INDUSTRIA E COMERCIO DE PRODUTOS PARA SAUDE LTDA CNPJ 10818693000188 RUA ALEXANDRE DUMAS 2100 10 ANDAR CHACARA SANTO ANTONIO SÃO PAULO SP TEL 1151800222 EMAIL SANDRABRAMUCCICRBARDCOM FABRICANTE DO PRODUTO BARD PERIPHERAL VASCULAR INC 1625 WEST 3RD STREET TEMPE AZ 85281 ESTADOS UNIDOS |
| Models | REBR0468, MC1410, REBP1199, REBQ0343, 80689090089 |
| Date | Aug 7, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1